BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX BALLOON CATHETER

    MDR report key: 2222061 · Received August 24, 2011

    Report

    Report Number
    2134265-2011-03643
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    July 23, 2011
    Report Date
    July 28, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4)

    Description of Event or Problem · 1

    (B)(4). SAME PATIENT AS MFR ID #: 2134265-2011-03640. SAME CASE AS MFR ID #: 2134265-2011-03870. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, VESSEL SPASM OCCURRED. THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA WITH DYSPNEA. IT WAS DETERMINED THAT THERE WAS EVIDENCE OF INFERIOR MYOCARDIAL INFARCTION OF UNDETERMINED AGE. CARDIAC CATHETERIZATION REVEALED A 100% STENOSED AND 16MM LONG TARGET LESION LOCATED IN THE FIRST RIGHT POSTEROLATERAL CORONARY ARTERY (1ST RPL) WITH A REFERENCE VESSEL DIAMETER OF 2.3MM. A 185 CM 0.014" FORTE GUIDE WIRE WAS PASSED ACROSS THE TOTALLY OCCLUDED 1ST RPL WITH SOME DIFFICULTY. A 1.5X12MM APEX BALLOON CATHETER WAS USED FOR ADDITIONAL SUPPORT. THE TARGET LESION WAS THEN PREDILATED IN THE OSTIAL AND PROXIMAL PORTION WITH THE APEX BALLOON WITH 6 INFLATIONS AT 10-16ATM FOR A MAXIMUM OF 46 SECONDS. THE APEX BALLOON WAS REMOVED AND ANGIOGRAPHY REVEALED 50% RESIDUAL STENOSIS IN THE PROXIMAL PORTION OF THE 1ST RPL AND PROBABLE DIFFUSE SPASM DISTALLY. THIS WAS TREATED WITH 200MCG OF INTRACORONARY NITROGLYCERIN WHICH SIGNIFICANTLY INCREASED THE DIAMETER OF THE VESSEL. A 2.25X20MM TAXUS LIBERTE STENT WAS THEN DEPLOYED AT 16ATM FOR 60 SECONDS RESULTING IN 0% RESIDUAL STENOSIS AND TIMI-3 FLOW. THE PATIENT WAS DISCHARGED 2 DAYS LATER ON ASPIRIN AND PRASUGREL.

    Description of Event or Problem · 1

    (B)(6) STUDY. SAME PATIENT AS MFR ID#: 2134265-2011-03640. SAME CASE AS MFR ID#: 2134265-2011-03870. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, VESSEL SPASM OCCURRED. THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA WITH DYSPNEA. IT WAS DETERMINED THAT THERE WAS EVIDENCE OF INFERIOR MYOCARDIAL INFARCTION OF UNDETERMINED AGE. CARDIAC CATHETERIZATION REVEALED A 100% STENOSED AND 16MM LONG TARGET LESION LOCATED IN THE FIRST RIGHT POSTEROLATERAL CORONARY ARTERY (1ST RPL) WITH A REFERENCE VESSEL DIAMETER OF 2.3MM. A 185 CM 0.014" FORTE GUIDE WIRE WAS PASSED ACROSS THE TOTALLY OCCLUDED 1ST RPL WITH SOME DIFFICULTY. A 1.5X12MM APEX BALLOON CATHETER WAS USED FOR ADDITIONAL SUPPORT. THE TARGET LESION WAS THEN PREDILATED IN THE OSTIAL AND PROXIMAL PORTION WITH THE APEX BALLOON WITH 6 INFLATIONS AT 10-16ATM FOR A MAXIMUM OF 46 SECONDS. THE APEX BALLOON WAS REMOVED AND ANGIOGRAPHY REVEALED 50% RESIDUAL STENOSIS IN THE PROXIMAL PORTION OF THE 1ST RPL AND PROBABLE DIFFUSE SPASM DISTALLY. THIS WAS TREATED WITH 200MCG OF INTRACORONARY NITROGLYCERIN WHICH SIGNIFICANTLY INCREASED THE DIAMETER OF THE VESSEL. A 2.25X20MM TAXUS LIBERTE STENT WAS THEN DEPLOYED AT 16ATM FOR 60 SECONDS RESULTING IN 0% RESIDUAL STENOSIS AND TIMI-3 FLOW. THE PATIENT WAS DISCHARGED 2 DAYS LATER ON ASPIRIN AND PRASUGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE UNK21

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention 185 CM 0.014" FORTE GUIDE WIRE